evo820 provides a variety of FDA Regulatory Compliance consulting services and resources to help every company and organization effectively and efficiently reach their goals. evo820 is Quality and Compliance defined.
We provide the expertise to obtain the US FDA 510(k) Clearance for companies wanting to distribute medical devices in the United States.
We support our clients with development of a Quality Management System (QMS) that is compliant with the FDA’s Title 21 CFR 820 that guides companies on the FDA current Good Manufacturing Practices and provides the training on how to install a QMS and manage the documentation.
evo820 Audits your QMS to assure that you are prepared for the FDA Inspection and have all your documents in order.
When the FDA announces that an FDA inspector is coming, we work with our clients to prepare for the FDA Audit.
The FDA’s Audit resulting in 483s or Warning letters, evo820 will assist with the appropriate response to the FDA and satisfy their required corrections from the FDA Audit.
evo820 stands with their clients to assure success in maneuvering the FDA requirements.